The embodiments described herein relate generally to the field of ophthalmic therapies and more particularly to ocular injection devices, packaging systems and kits for delivery of a substance, such as a fluid therapeutic agent into ocular tissues for treatment of the eye.
Although injection is used in intraocular drug delivery, there remains a need for improved injection devices, kits, and methods, particularly for delivery of substances (e.g., drugs) into the posterior region of the eye. For example, in certain situations, direct injection of a medicament into the eye (e.g., into the vitreous) using conventional 27 gauge or 30 gauge needles and syringes can be effective. Direct injection, however, can be associated with significant safety risks. Such risks include, for example, controlling the needle depth and placement to deliver the medicament to the desired location (e.g., the suprachoroidal space (SCS) of the eye or the subretinal space (SRS) of the eye). It can be desirable, therefore for a kit or injection system to include a needle assembly that can vary or otherwise allow for different needle lengths during an injection procedure. It can also be desirable for a kit or injection system to include multiple interchangeable needles having different lengths to allow a practitioner to select the appropriate needle length at the time of an operation.
Needle insertion and injection can be further complicated in procedures where, due to the small needle size and/or the characteristics of the injected drug, delivery involves the use of force levels higher than that which users are comfortable with applying. For example, some studies have shown that users generally do not like to apply more than 2 N force against the eye during ocular injection. Accordingly, in certain situations a user may not properly deliver the medicament using known systems and methods because of their reluctance to apply the force to fully expel the medicament.
In addition to the issues surrounding the mechanics of needle insertion and injection, known kits and methods are also susceptible to risks associated with contamination. For example, known methods for accessing the eye include establishing a sterile field that is free of potentially harmful pathogens and/or microorganisms. Known kits, however, may include non-sterile portions (such as the exterior of the packaging, instructions or the like) that can contaminate the sterile field when the injection components are unpackaged and prepared for use.
Moreover, known some known kits are cumbersome to unpack and lack features that facilitate maintenance, handling, and/or manipulation of the components within a sterile field. For example, certain procedures may include preparing a dose of medicament within the sterile environment (e.g., within the sterile field) before delivery. The dose can be prepared, for example, by withdrawing a predetermined amount of a medicament from a vial into an injection device, by mixing one or more medicaments, by reconstituting a lyophilized medicament, or the like. Such dose preparation procedures can include handling one or more medicament containers, coupling the medicament containers to a delivery device (e.g., an ocular injector), and coupling a needle (or other delivery member) to the delivery device. Known kits, devices, and methods, however, often do not facilitate preserving the sterile field when such dose preparation and needle coupling operations are performed.
Thus, a need exists for improved injection devices, packaging systems and kits for ocular injection.